US20060161050A1

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Publication number: US20060161050A1
Application number: US11/291,089
Authority: US
Inventors: John Butler; Trevor Vaugh; Frank Bonadio
Original assignee: Individual
Current assignee: Atropos Ltd
Priority date: 2003-10-15
Filing date: 2005-12-01
Publication date: 2006-07-20

Abstract

A surgical sealing device (405), suitable for use during a surgical procedure such as a laparoscopic procedure or a hand-assisted laparoscopic procedure, comprises a first sealing member (5) and a second sealing member (6). A thin slit is defined between the sealing members (5, 6). In a closed configuration, the first sealing member (5) overlaps the distal end opening of a passageway (2) through the second sealing member (6) to prevent leakage of insufflation gases out of an abdomen (4). In an open configuration, the first sealing member (5) is retracted to reveal the distal end opening of the passageway (2) and thus facilitate passage of an object, such as a surgeon's hand or forearm (3), into the abdomen (4). The device (405) comprises a planar support element (406) fixedly attached to the proximal exterior surface (408) of the first sealing member (5). The first sealing member (5) is fixedly attached to the second sealing member (6) at an attached region (409), with a detached region (407) remaining detached from the second sealing member (6). The support element (406) acts as a stiffening element to increase the stiffness of the detached region (407) of the first sealing member (5) to minimise the deformation of the detached region (407) of the first sealing member (5) when the surgeon's hand/forearm (3) is pushed through the passageway (2). It is thus easier for the surgeon to retract the first sealing member (5) laterally to reveal the distal end opening of the passageway (2) by pushing the hand/forearm (3) through the passageway (2) and easier for the surgeon to pass the hand/forearm (3) through the device (405) and gain access to the abdomen (4).

Description

INTRODUCTION

This invention relates to a surgical sealing device suitable for use during a surgical procedure, especially suitable for use during laparoscopic surgery or during hand assisted laparoscopic surgery.

In carrying out a surgical procedure in the region of the abdomen, it is known to form an incision and then retract the sides of the incision to provide an access opening. The opening may be sealed with a valve in an effort to prevent insufflation gases from escaping and to maintain pneumoperitoneum. It is however difficult to provide an effective gas seal while providing access for an instrument or for a surgeon's hand.

This invention is directed towards providing a surgical sealing device, which will address these problems.

STATEMENTS OF INVENTION

According to the invention there is provided a surgical sealing device comprising:

- a first sealing valve for sealing across an opening to an internal cavity;
- the first sealing valve comprising a first sealing member and a second sealing member;
- the sealing members being movable relative to one another between a closed configuration, in which the sealing members at least partially overlap one another, for sealing across the opening, and an open configuration for facilitating passage of an object through the first sealing valve to access the internal cavity; and
- at least one support element for at least partially supporting at least one of the sealing members to facilitate ease of passage of the object through the first sealing valve.

In one embodiment of the invention the support element is configured to at least partially support the sealing member to facilitate ease of movement of the sealing members relative to one another from the closed configuration to the open configuration. The support element may be configured to minimise deformation of at least part of the sealing member.

In one case the sealing member is substantially planar. The support element may be configured to minimise deformation of at least part of the sealing member in a direction substantially perpendicular to the plane of the sealing member.

The support element may be substantially planar.

In another embodiment the sealing members are fixedly attached to one another, each sealing member having a first region attached to the other sealing member and a second region which remains detached from the other sealing member. The support element may be configured to minimise deformation of the second region of the sealing member.

In one case the support element comprises a stiffening element to increase the stiffness of at least part of the sealing member.

The support element may be attached to the sealing member. In one case the support element is attached to an exterior surface of the sealing member. The support element may be embedded within the sealing member.

In one embodiment of the invention at least one of the sealing members is at least partially of a gelatinous elastomeric material. In one case both sealing members are at least partially of a gelatinous elastomeric material. In another case the material comprises a plasticiser. The plasticiser may be selected from the group consisting of naturally derived oils, synthetic oils and liquid oligomers.

In one case the first sealing valve is biased towards the closed configuration. In one case at least one of the sealing members is of a resilient material to bias the first sealing valve towards the closed configuration.

The first sealing member and the second sealing member may define overlapping portions, which overlap with each other in the closed configuration. In one case at least the overlapping portions of the sealing members are generally planar. In another case the planes of the overlapping portions are slightly offset. In another case the overlapping portions engage with each other in the closed configuration. The engagement force is in one case overcome on insertion of an object, such as a surgeon's hand.

In another embodiment a thin slit is defined between the overlap of the first sealing member over the second sealing member.

The first sealing member may be fixedly attached to the second sealing member. In one case the first sealing member is formed integrally with the second sealing member. In another case the first sealing member is moulded integrally with the second sealing member. In one case the first sealing member comprises an overlap region, which overlaps the second sealing member in the closed configuration, the overlap region comprising a first region attached to the second sealing member and a second region detached from the second sealing member. In one case a thin slit is defined between the second region of the first sealing member and the second sealing member. In another case the slit extends circumferentially through approximately 90°. The ratio of the radial dimension of the slit to the overall radial dimension of the entire first sealing member may be approximately 1:4, in one case approximately 1:8.

In a preferred case in the closed configuration, the second region of the first sealing member engages the second sealing member. In another case the second region of the first sealing member is biased towards engagement with the second sealing member.

The first sealing valve may be configured to be located externally of an internal cavity proximally of an opening to the internal cavity. The first sealing valve may be configured to be located within an internal cavity distally of an opening to the internal cavity.

The first sealing member is in one case substantially planar. The second sealing member is in one case substantially planar.

In a preferred embodiment the device comprises a second sealing valve for sealing around an object passed through an opening to an internal cavity.

The first sealing member may be located distally of the second sealing valve. The first sealing valve may be located proximally of the second sealing valve.

In one case the first sealing valve is longitudinally spaced apart from the second sealing valve. One sealing valve may be configured to be located externally of an internal cavity proximally of an opening to the internal cavity, and the other sealing valve may be configured to be located within the internal cavity distally of the opening.

In another case the first sealing valve is located adjacent to and in close proximity to the second sealing valve. Both the first sealing valve and the second sealing valve may be located externally of an internal cavity proximally of an opening to the internal cavity. Both the first sealing valve and the second sealing valve may be located within an internal cavity distally of an opening to the internal cavity.

In one case the second sealing member provides the second sealing valve. In another case the second sealing member has a passageway extending therethrough, through which an object may be inserted to access an internal cavity. The second sealing member may be configured to effect a seal between a sidewall of the passageway and an object inserted through the passageway.,

In one case, in the closed configuration, the first sealing member extends across an end of the passageway and overlaps the second sealing member around the entire periphery of the end of the passageway. In one case in the open configuration the first sealing member is retracted to reveal at least part of the end of the passageway.

The second sealing valve may comprise a lip seal valve.

In a further embodiment the device is mountable to a retractor device. In one case the device comprises a mounting element for mounting the device to a retractor device. In another case the mounting element is fixedly attached to the sealing valve. In another case a part of the sealing valve is overmoulded around a part of the mounting element. The mounting element may comprise one or more overmould openings therein. In one case the mounting element comprises an engagement formation for snap-fit mounting of the device to a retractor device.

The mounting element may comprise a ring element.

In one case the device is configured to effect a seal between the device and a retractor device upon mounting of the device to the retractor device. In another case at least one of the sealing members is configured to engage a retractor device upon mounting.

In another embodiment the first sealing valve comprises a biasing member to bias the first sealing valve towards the closed configuration. In one case the biasing member comprises a resilient element extending between the first sealing member and the second sealing member. The resilient element may comprise a spring.

The biasing member may comprise a magnetic element on the first sealing member and a co-operating magnetic element on the second sealing member.

In another case the first sealing valve comprises a biasing member to bias the second region of the first sealing member towards engagement with the second sealing member. In one case the biasing member comprises a resilient element for tensioning the second region of the first sealing member. In another case the resilient element extends between the second region of the first sealing member and the second sealing member.

In one case the first sealing member is hingeably movable relative to the second sealing member between the closed configuration and the open configuration.

The first sealing member may be at least partially curved.

The first sealing member may be at least partially substantially spherical. The second sealing member may be substantially curved.

In the closed configuration, the first sealing member may extend at least partially into the passageway.

In another embodiment the thickness of the second sealing member varies across the width of the second sealing member. In one case the thickness of the second sealing member is at a maximum adjacent the passageway.

The passageway may define a longitudinal axis, and the passageway longitudinal axis may be configured to subtend an acute angle with a longitudinal axis defined by an opening to an internal cavity. In one case the longitudinal axis of the passageway is angled towards the second region of the first sealing member.

In another case the device comprises a closure member for closing the passageway. In one case the closure member comprises a plug.

In one embodiment the second sealing valve comprises a third sealing member having a passageway extending therethrough, through which an object may be inserted to access an internal cavity. In one case the third sealing member is configured to effect a seal between a wall of the passageway and an object inserted through the passageway. In another case the third sealing member is at least partially of a gelatinous elastomeric material.

The second sealing valve may be at least partially inflatable. The second sealing valve may comprise an iris valve.

In a further case the device comprises a third sealing valve for sealing across an opening to an internal cavity. In one case the third sealing valve comprises a fourth sealing member, the second sealing member and the fourth sealing member being movable relative to one another between the closed configuration, in which the second sealing member and the fourth sealing member at least partially overlap one another, and the open configuration. In another case the fourth sealing member is at least partially of a gelatinous elastomeric material.

The mounting element may comprise a screw-thread formation for screw-thread mounting of the device to a retractor device.

In one case the mounting element comprises a sleeve extending proximally of the sealing valve. In one case the sleeve is hookable around a part of a retractor device to mount the device to the retractor device. The sleeve may comprise a mounting ring for hooking around a part of a retractor device.

According to another aspect, the invention provides a surgical assembly comprising:

- a retractor device for retracting the sides of an opening to an internal cavity; and
- a surgical sealing device of the invention.

In one case the surgical sealing device is mounted to the retractor device.

The retractor device may have a distal end and a proximal end, and the surgical sealing device may be located adjacent to the distal end of the retractor device. The retractor device may have a distal end and a proximal end, and the surgical sealing device may be located adjacent to the proximal end of the retractor device.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view from above of a surgical sealing device according to the invention;

FIG. 2 is a perspective view from below of the device ofFIG. 1;

FIG. 3 is a plan view from above of the device ofFIG. 1;

FIG. 4 is a side view in the direction of arrow A inFIG. 3;

FIG. 5 is a view along line V-V inFIG. 3;

FIG. 6 is a view along line VI-VI inFIG. 3;

FIG. 7 is a partially cross sectional, side view of the device ofFIG. 1, in use;

FIG. 8 is a partially cross-sectional, side view of the device ofFIG. 1 mounted to a retractor device;

FIG. 9 is a perspective view of a mounting element for the device ofFIG. 1;

FIG. 10 is a cut-away, perspective view of the mounting element ofFIG. 9;

FIG. 11 is a cross-sectional, side view of the device ofFIG. 1 and the mounting element ofFIG. 9;

FIG. 12 is a cut-away, perspective view of the device ofFIG. 1 and the mounting element ofFIG. 9;

FIG. 13 is a cross-sectional, side view of the device ofFIG. 1 and the mounting element ofFIG. 9 mounted to a retractor device;

FIG. 14 is a perspective view illustrating mounting of the device ofFIG. 1 and another mounting element to another retractor device;

FIG. 15 is a cross-sectional, side view of another surgical sealing device according to the invention;

FIG. 16 is a perspective view of a part of the device ofFIG. 15;

FIGS.17 to21 are cross-sectional, side views of other surgical sealing devices according to the invention;

FIGS. 22 and 23 are plan views from above of further surgical sealing devices according to the invention;

FIGS. 24 and 25 are perspective views of another surgical sealing device according to the invention;

FIG. 26 is a cross-sectional, side view of the device ofFIG. 25;

FIG. 27 is a perspective view of another surgical sealing device according to the invention;

FIG. 28 is a perspective view of a further surgical sealing device according to the invention;

FIG. 29 is a side view of the device ofFIG. 28;

FIG. 30 is a plan view of the device ofFIGS. 28 and 29 with an object, such as a surgeon's arm, in position;

FIG. 31 is a perspective view of another surgical sealing device according to the invention;

FIG. 32 is plan view of the device ofFIG. 31;

FIG. 33 is a cross sectional, side view of the device ofFIG. 31;

FIGS. 34 and 35 are partially cross sectional, side views illustrating the device of FIGS.31 to33, in use;

FIGS. 36 and 37 are cross sectional, side views of other surgical sealing devices according to the invention;

FIG. 38 is a perspective view of a lip seal used in some aspects of the invention;

FIGS. 39 and 40 are cross sectional, side views of another surgical sealing device according to the invention incorporating a distal overlap valve and a proximal lip seal;

FIG. 41 is a partially cross sectional, side view of the device ofFIGS. 39 and 40, in use;

FIG. 42 is a cross sectional, side view of another surgical sealing device according to the invention mounted to a retractor device;

FIG. 43 is a partially cross sectional, side view of the device ofFIG. 42, in use;

FIG. 44 is a cross sectional, side view of another surgical sealing device according to the invention with a distal overlap valve and a lip seal located proximally adjacent to the overlap valve;

FIG. 45 is a partially cross sectional, side view of the device ofFIG. 44, in use;

FIG. 46 is a cross sectional, side view of another surgical sealing device according to the invention with a lip seal and an overlap valve located proximally of a retractor device;

FIG. 47 is a cross sectional, side view of another surgical sealing device according to the invention with an overlap valve incorporating a lip seal;

FIG. 48 is a partially cross sectional, side view of the device ofFIG. 47, in use;

FIG. 49 is a cross sectional, side view of a further surgical sealing device according to the invention incorporating a secondary valve;

FIGS.50 to53 are partially cross sectional, side views of the device ofFIG. 49, in use;

FIG. 54 is a plan view of the secondary valve of the device ofFIG. 49 in the configuration ofFIG. 53;

FIG. 55 is a cross sectional, side view of another surgical sealing device according to the invention mounted to a retractor device;

FIG. 56 is a partially cross sectional, side view of the device ofFIG. 55, in use;

FIG. 57 is a cross sectional, side view of another surgical sealing device according to the invention in one configuration of use;

FIG. 58 is a cross sectional, side view of the device ofFIG. 57 in another configuration of use;

FIG. 59 is a partially cross sectional, side view of the device ofFIGS. 57 and 58 with a hand inserted;

FIG. 60 is a cross sectional, side view of another surgical sealing device according to the invention mounted to a retractor device;

FIG. 61 is a cross sectional, side view of another surgical sealing device according to the invention mounted to a retractor device;

FIG. 62 is a perspective view of a secondary valve of the device ofFIG. 61;

FIG. 63 is an exploded, perspective view of another surgical sealing device according to the invention;

FIG. 64 is a cross-sectional, side view of the device ofFIG. 63;

FIGS.65 to67 are perspective views from below of further surgical sealing devices according to the invention;

FIG. 68 is a plan view from below of the device ofFIG. 67;

FIG. 69 is a cross-sectional, side view of another surgical sealing device according to the invention;

FIG. 70 is a partially cross-sectional, side view of the device ofFIG. 69, in use;

FIG. 71 is a partially cross-sectional, side view of a further surgical sealing device according to the invention;

FIG. 72 is a perspective view from below of the device ofFIG. 71;

FIG. 73 is a partially cross-sectional, side view of another surgical sealing device according to the invention;

FIG. 74 is a partially cross-sectional, side view of the device ofFIG. 73, in use;

FIG. 75 is a perspective view from below of another surgical sealing device according to the invention;

FIGS. 76 and 77 are cross-sectional, side views of the device ofFIG. 75;

FIG. 78 is a partially cross-sectional, side view of the device ofFIG. 75, in use; and

FIGS. 79 and 80 are views similar toFIGS. 75 and 76 of a further surgical sealing device according to the invention.

DETAILED DESCRIPTION

Referring to the drawings and initially to FIGS.1 to8 thereof, there is illustrated asurgical sealing device1 according to the invention, which is suitable for use during a surgical procedure, such as a laparoscopic procedure or a hand-assisted laparoscopic procedure.

Thedevice1 may in the case of a laparoscopic procedure be employed to effect a seal around a laparoscopic instrument inserted through thedevice1 into an abdomen to maintain insufflation gas pressure within the abdomen. In the case of a hand-assisted laparoscopic procedure, thedevice1 may be employed to effect a seal around a surgeon's hand or forearm inserted through thedevice1 into the abdomen to maintain insufflation gas pressure within the abdomen.

Thedevice1 comprises a planar first sealingmember5 and a planarsecond sealing member6. Thesecond sealing member6 has apassageway2 extending therethrough through which an object, such as a laparoscopic instrument or a surgeon's hand/forearm3, may be inserted to access an interior space, such as aninsufflated abdomen4. The planar first sealingmember5 may be employed to seal thepassageway2.

In this case, thefirst sealing member5 is provided in the form of a flap member of an elastic material. Theflap member5 is movable relative to thesecond sealing member6 between a closed configuration sealing the passageway2 (FIG. 5), and an open configuration to facilitate insertion of an object, such as the surgeon'sforearm3 through thepassageway2 to access the abdomen4 (FIG. 7). In the closed configuration, theflap member5 extends across the distal end of thepassageway2 and overlaps the entire periphery of the distal end of thepassageway2 to prevent leakage of the insufflation gas out of the abdomen4. The insufflation gas pressure within theabdomen4 forces theflap member5 into engagement with thesecond sealing member6 in the closed configuration. In the open configuration, theflap member5 is retracted to reveal the distal end of thepassageway2 to enable an object, such as the surgeon's hand/forearm3 to pass through thesealing device1 and into the abdomen4. In this manner theflap member5 defines an overlap seal.

Insertion of the object, such as the hand/forearm3 through thepassageway2 pushes against theflap member5 to cause retraction of theflap member5.

In this case thefirst sealing member5 and thesecond sealing member6 are formed integrally, in this case moulded integrally. In the closed configuration, thefirst sealing member5 overlaps thesecond sealing member6 around the entire periphery of the distal end opening of thepassageway2. In this region of overlap, thefirst sealing member5 is fixedly attached to thesecond sealing member6 at anattachment region7, and is detached from thesecond sealing member6 at adetachment region8. As illustrated in FIGS.2 to6, thedetachment region8 is in the form of a very thin slit or gap. The slip/gap8 extends circumferentially through approximately 90°, and has a radial dimension approximately ¼ of the radial width of thefirst sealing member5, and approximately ⅛ of the radial width of thesecond sealing member6. In the closed configuration, the insufflation gas pressure within theabdomen4 forces thedetachment region8 to engage against thesecond sealing member6 around the distal end of thepassageway2. This results in the thin slit/gap being closed down to prevent leakage of insufflation gas out of the abdomen4.

Because theregion8 is detached from thesecond sealing member6, this arrangement enables theregion8 to be retracted when an object is inserted through thepassageway2, which results in the slit/gap becoming large enough for the object to exit thepassageway2 and access theabdomen4. As the object passes through thepassageway2, the object engages theregion8 and forces theregion8 aside. In this manner, theregion8 is retracted.

Because thefirst sealing member5 and thesecond sealing member6 overlap in the closed configuration, a seal is created across the wound opening which prevents loss of insufflation gases from the abdomen4. The overlapping first and

second sealing members

5,6 thus provide a first sealing valve for sealing across the wound opening.

The elastic biasing nature of theflap member5 biases theflap member5 towards the closed configuration to prevent leakage of insufflation gas out of theabdomen4, when the surgeon withdraws the object, such as the hand/forearm3 out of the abdomen4. In particular the resilience of the material of theflap member5 biases theflap member5 towards the closed configuration. In addition, the gas pressure within theabdomen4 acts on theflap member5 to force theflap member5 towards the closed configuration.

The sidewall of thepassageway2 is of an elastic material, and thepassageway2 typically has a smaller diameter than an object to be inserted therethrough. The material defining thepassageway2 thus creates a seal between the sidewall of thepassageway2 and the object, defining an interference fit between the sidewall and the object (FIG. 7). In this manner, thepassageway2 through thesecond sealing member6 acts as a second sealing valve to seal around the object while the object is inserted through thepassageway2 and into the abdomen4. In particular thepassageway2 acts as a lip seal. Thus leakage of insufflation gas out of theabdomen4 while the object is inserted through thepassageway2 and into theabdomen4 is prevented.

In the case of laparoscopic surgery, thepassageway2 is sized to seal around a laparoscopic instrument inserted therethrough. Thepassageway2 may therefore be sized as a pinhole through thesecond sealing member6. In certain cases, thesecond sealing member6 may be formed with no hole therethrough, and thepassageway2 may be created in-situ by the surgeon piercing thesecond sealing member6 with the instrument and forcing the instrument through thesecond sealing member6.

In the case of hand-assisted laparoscopic surgery, thepassageway2 is sized to seal around a hand or forearm of the surgeon.

As illustrated inFIG. 7, the first sealing overlap valve provided by theflap member5 is located longitudinally distally of the second sealing lip seal valve provided by thepassageway2.

However it will be appreciated that the first sealing valve may alternatively be provided proximally of the second sealing valve.

Thesealing device1 may be mounted to awound retractor device10, as illustrated inFIG. 8. The mounting may be in any convenient manner such as a releasable mounting using a bayonet type mounting or the like as will be described in more detail below. The gas pressure within theabdomen4, after insufflation, pushes up on thefirst sealing member5, causing thefirst sealing member5 to engage against thesecond sealing member6 to maintain pneumoperitoneum.

Thedevice1 is in this case a combined overlap/lipseal valve for hand assisted laparoscopy (HALS).

Thedevice1 may be a single piece moulded gel component. The first and

second sealing members

5,6 are both formed of a gel material. The gel material may include an elastomer, such as silicone or latex. The gel material may also include an oil, and/or a foam.

In one embodiment thedevice1 is of a gelatinous elastomeric material. An extensive review of gelatinous elastomeric materials is included inUS5,994,450 (Pierce), the entire contents of which are incorporated herein by reference. One such group of gelatinous elastomers may comprise a triblock copolymer A-B-A wherein A is selected from the group consisting of monoalkenylarene polymers and B is a hydrogenated polymer including a plurality of isoprene monomers and a plurality of butadiene monomers. The material includes a plasticiser which may be selected from the group consisting of naturally derived oils, synthetic oils and liquid oligomers. For the device of this embodiment of the invention the gelatinous elastomeric material is formulated to have high tear strength and high flexibility.

The materials required to form a suitable gel material are available, for example, from the company Edizone L.C. of Utah, USA. The gel material preferably has the properties of high tear strength to resist tearing of the attachment of thefirst sealing member5 to thesecond sealing member6, and high flexibility to enable thefirst sealing member5 to be retracted for passage of an object through thepassageway2 into the abdomen4.

During moulding, a thin plate is located between thefirst sealing member5 and thesecond sealing member6. This thin plate prevents thefirst sealing member5 being fully moulded to thesecond sealing member6. As a result thefirst sealing member5 is moulded to thesecond sealing member6 at a first region which is theattachment region7, and remains un-moulded to thesecond sealing member6 at a second region which is thedetachment region8. This thin plate defines the thin slit/gap8 between the sealing

members

5,6.

In certain applications the device may alternatively be formed as a single piece moulded rubber or elastomeric component.

There is alipseal hole2 through which an object, such as hand can pass, due to the highly elastic nature of the material. Anoverlap flap5 is integrally moulded underneath, and covering, thelipseal hole2. Theoverlap flap5 is essentially joined to/integral with the main body of the lipseal apart from a slit which in this case extends radially. Because of the elastic nature of the material, the object, such as the hand can displace theoverlap flap5 and push through the slit. In use, the slit is closed by the gas pressure acting upwardly on theflap5. On insertion of an object the slit can be opened just sufficiently to allow the object to pass therethrough with no substantial loss of gas pressure. Thelipseal2 now seals to the object, such as the surgeon's wrist, maintaining pneumoperitoneum. When the object, such as the hand/forearm3 is removed, theoverlap flap5 returns to its original position blocking thelipseal hole2.

In the case where the surgical sealing device of the invention is employed during laparoscopic surgery, thesecond sealing member6 may alternatively be formed as a continuous single block of gel with no passageway extending therethrough. When the device is mounted across a wound opening sealing the opening, the surgeon may pierce thesecond sealing member6, for example with a laparoscopic instrument having a sharp distal tip to create the passageway through thesecond sealing member6 in situ by pushing the instrument through thesecond sealing member6.

FIGS. 9 and 10 illustrate a mountingring20 suitable for use when mounting thedevice1 of FIGS.1 to8 to a wound retractor device. A wound retractor device is typically employed to retract the sides of a wound opening to the abdomen4. Thering20 is sufficiently rigid to enable thedevice1 to be mounted to the retractor device in a stable manner.

Thering20 includes a series of oblong openings orslots21 therein, in both the vertical and horizontal planes. Theslots21 assist in obtaining a secure attachment of thedevice1 to the ring20 (FIGS. 11 and 12).

One method of attaching thedevice1 to thering20 is by overmoulding a part of thesecond sealing member6 around parts of thering20. Theslots21 thus provide pathways for thesecond sealing member6 to mould around parts of thering20 to fixedly attach thedevice1 to thering20.

Because the first and

second sealing members

5,6 are moulded integrally, the process of moulding thedevice1 and attaching thedevice1 to thering20 may be performed in a single moulding step.

It will be appreciated that thedevice1 may be fixedly attached to the mountingring20 in a variety of possible alternative ways. For example, thedevice1 may be securely attached to thering20 using an adhesive or any other suitable fixing means.

Thering20 includes a downwardly extendingrim22 having an inwardly protrudingengagement lip23. Thelip23 is particularly suitable for mounting thering20 and theovermoulded device1 to a retractor device in a snap-fit manner. For example, in the case of thewound retractor device27 ofFIG. 13, theretractor device27 has a co-operating outwardly extendingledge28 for snap-fit mounting of thering20 andovermoulded device1 to thewound retractor device27.

As illustrated inFIG. 13, thesecond sealing member6 protrudes distally to engage thewound retractor device27, when thering20 andovermoulded device1 are mounted to theretractor device27. This arrangement creates a gas-tight seal between thedevice1 and thewound retractor device27, and thus acts as a further means of preventing loss of insufflation gases.

The mounting ring may be mounted to a wound retractor device in any suitable manner. For example, screw-thread formations31 may be provided on thering30, and co-operating screw-thread formations33 may be provided on thewound protector device32, as illustrated inFIG. 14, for screw-thread mounting of thering30 andovermoulded device1 to theretractor device32.

InFIGS. 15 and 16, there is illustrated anothersurgical sealing device40 according to the invention, which is similar to thedevice1 of FIGS.1 to8, and similar elements inFIGS. 15 and 16 are assigned the same reference numerals.

In this case, thefirst sealing member5 includes ahemispherical portion41. In the closed configuration, thehemispherical portion41 extends partially into thepassageway2 to achieve a particularly effective seal.

To ensure that thefirst sealing member5 engages thesecond sealing member6 around the entire periphery of the distal end of thepassageway2 in the closed configuration, the thickness of thesecond sealing member6 may vary, across the width of thesecond sealing member6. A variety of possible configurations for thesecond sealing member6 are illustrated in FIGS.17 to19. By arranging for the thickness of thesecond sealing member6 to be at a maximum adjacent thepassageway2, the sealing effect may be enhanced.

By arranging for the proximal side of thesecond sealing member6 to curve proximally away from the distal end of the passageway2 (FIGS. 18 and 19), it has been found to result in a better sealing arrangement in certain clinical applications. Thefirst sealing member5 is also curved in these cases to mate with the curvedsecond sealing member6 in the closed configuration (FIGS. 18 and 19).

In the embodiments ofFIGS. 17 and 18, the raised material of thesecond sealing member6 puts weight on the overlapping first sealingmember5 to maintain an effective seal. The curved/domed surfaces of thefirst sealing member5 and thesecond sealing member6 improve the sealing inFIG. 19.

Thepassageway2 may be arranged so that the passageway longitudinal axis A-A subtends an acute angle with the longitudinal axis B-B of the wound opening, and thepassageway2 is angled towards thedetachment region8, as illustrated inFIG. 20.

In this manner, thepassageway2 effectively guides the instrument or surgeon's hand in the direction of thedetachment region8 of thefirst sealing member5. This assists in a faster and smoother insertion through thepassageway2 and retraction of thefirst sealing member5.

An additional sealingmember50 may be provided integrally moulded with thesecond sealing member6, as illustrated inFIG. 21. This fourth sealingmember50 is similar to thefirst sealing member5, and is also provided in the form of an overlapping flap. In the closed configuration, the fourth sealingmember50 overlaps the entire periphery of the proximal opening of thepassageway2. In this manner, the overlap of the fourth sealingmember50 over thesecond sealing member6 creates a third sealing valve to achieve a gas-tight seal across the wound opening. Thefourth sealing member50 is movable relative to thesecond sealing member5 from the closed configuration to the open configuration to facilitate insertion of an instrument or a surgeon's hand into thepassageway2.

In this case, the fourth sealingmember50 is of the same gelatinous elastomeric material as the first and

second sealing members

5,6, and may be integrally formed.

A biasing member may be provided to bias thefirst sealing member5 towards the closed configuration. For example,FIG. 22 illustrates a “U”-shaped resilient leaf-spring member60 for tensioning thedetachment region8 of thefirst sealing member5 in the plane of thefirst sealing member5. By tensioning in this plane, the leaf-spring60 biases thedetachment region8 of thefirst sealing member5 into engagement with thesecond sealing member6. In this manner, an effective seal may be achieved.

FIG. 23 illustrates an alternative resilient biasing member. In this case twosprings61,62 are provided extending between thedetachment region8 of thefirst sealing member5 and thesecond sealing member6 to tension thefirst sealing member5 in the plane of thefirst sealing member5.

FIGS.24 to26 illustrate anothersurgical sealing device70 according to the invention, which is similar to thedevice1 of FIGS.1 to8, and similar elements in FIGS.24 to26 are assigned the same reference numerals.

In this case, thedevice70 comprises aplug71 for insertion into thepassageway2 to close thepassageway2. By closing thepassageway2 with theplug71, this acts as a further seal to prevent loss of insufflation gases, for example during initial insufflation of the abdomen4.

Theplug71 is attached by means of a cord to thesecond sealing member6.

Referring now toFIG. 27 there is illustrated anothersurgical sealing device150 according to the invention. In this case thedevice150 has an overlap valve defined by a first sealing member153 partially overlapping asecond sealing member152. The properties of the elastomeric material of thedevice150, such as the sealingmembers152,153, is such as to closely surround an inserted object. Thus, there is substantially no leakage path between the inserted object and the valve body. Consequently, thedevice150 may be used without the necessity for another valve, there being sufficient sealing engagement between the sealingmembers152,153 and the inserted object to substantially prevent insufflation gas leakage.

Referring to FIGS.28 to30, there is illustrated anothersurgical sealing device200 according to the invention. Thedevice200 is formed from a highly elastomeric material, such as a silicone based gel. Thefirst sealing member202 and thesecond sealing member203 have relatively thin outer portions. At theattachment region201, the sealing

members

202,203 have a relatively thick central portion. The central portion has a detachment region slit205 therein which extends obliquely with respect to the axis of an incision to provide enhanced sealing between the marginal edge of the accessway defined by theslit205 and an object passing therethrough, as illustrated inFIG. 30. The valve in this case has high elasticity to comply with an object passing therethrough, and a secondary valve may therefore not be required.

Referring to FIGS.31 to35, there is illustrated asurgical sealing device101 according to the invention for use in a surgical procedure, such as laparoscopic surgery or hand assisted laparoscopic surgery. Thedevice101 comprises afirst sealing member102 and asecond sealing member103 which have a normally closed configuration (FIGS. 33 and 34) and an open configuration (FIG. 35). The sealing

members

102,103 extend across an opening, such as a retracted incision, and partially overlap each other in the closed configuration (FIG. 34). The sealing

members

102,103 are movable on insertion of an object, such a surgeon's hand/forearm105, to facilitate access between the sealingmembers102,103 (FIG. 35).

The sealing

members

102,103 have respective overlapping

portions

106,107 which overlap with each other in the closed configuration. The sealing

members

102,103 are generally planar, with the planes of the overlapping

portions

106,107 being slightly offset. The overlapping

portions

106,107 are at least partially engaged with one another in the closed configuration. In this case, the sealing

members

102,103 are of a resilient and elastomeric sheet material such as rubber, silicone or latex. The engagement force between the overlapping

portions

106,107 is overcome by the insertion of an object, such as a surgeon's hand.

In this case the sealing

members

102,103 are each mounted to a mounting ring in the form of an O-ring110. Asleeve112 extends proximally from the mounting O-ring110.

Referring toFIG. 36 there is illustrated anothersurgical sealing device120, in which parts similar to thedevice101 of FIGS.31 to35 are identified by the same reference numerals.

The sealing

members

102,103 are, in this case, of an elastic material such as a gel, neoprene, rubber or silicone which may optionally havefacings121,122 on the non-engaged side. Indeed, there may be a facing on the engaged side to enhance the engagement. In this case, the facings may have some adhesive or tackiness properties.

Referring toFIG. 37, in this case, asurgical sealing device130 has

magnets

131,132 situated in the

overlap portions

106,107 respectively to enhance engagement between the sealing

members

102,103 to maintain the seal in the closed configuration. The co-operating

magnetic elements

131,132 act as biasing members to bias thedevice130 towards the closed configuration.

Referring toFIG. 38 there is illustrated athird sealing member1000, in this case in the form of a lipseal type valve1000 which may be used as a second sealing valve. Thelip seal1000 has a passageway extending therethrough, through which an object may be inserted. The passageway effects a seal between the sidewall of the passageway and the object inserted therethrough. Thelip seal valve1000 may be located distal to or within the first sealing valve, such as anoverlap valve1100. Theoverlap valve1100 may be of any of the types described above, and like parts are assigned the same reference numerals.

Referring to FIGS.39 to41, theoverlap valve1100 is located just inside an incision. Thevalve1100 is coupled to a retractor located in the incision at a surgical site, such as in anabdominal wall141.

The retractor may be of any suitable construction such as the retractors described in our US patent application published under No. 2001/0037053A, and/or U.S. Pat. No. 6,582,364, and/or U.S. patent application Ser. No. 10/678,653, the whole contents of which are incorporated herein by reference.

In this case, the retractor has adistal ring142 and aproximal ring143 with a retractingsleeve144 extending therebetween, as illustrated. The retractor also has a proximal guide or mountingring145. In this case, theproximal ring143 is located in a recess in the guide-mountingring145, however various other constructions are possible. Thevalve sleeve112 is mounted to the retractor, in this case to the mountingring145. The distal end of thevalve sleeve112 has a reinforcing mountingring146 to facilitate coupling, as shown. In particular the reinforcingring146 may be hooked around the mountingring145 to mount thedevice1100 to the retractor.

Thelip seal1000 is attached to the mountingring45 of the retractor.

Referring toFIGS. 42 and 43, there is illustrated another surgical assembly similar to that of FIGS.39 to41, and like parts are identified by the same reference numerals. In this case, the second sealing valve is provided by alip seal valve160. Thelip seal160 may be of any suitable material such as silicone, gel or rubber.

The firstsealing overlap valve1100 is located within the abdomen distally of the wound opening, and the second sealinglip seal valve160 is located externally of the abdomen proximally of the wound opening. As illustrated, thefirst sealing valve1100 is longitudinally spaced apart from thesecond sealing valve160.

Referring toFIGS. 44 and 45, there is illustrated another surgical assembly according to the invention, which is similar to the assembly of FIGS.39 to41, and similar elements inFIGS. 44 and 45 are assigned the same reference numerals.

In this case, the second sealingvalve lip seal1000 is located just proximal of, adjacent and in close proximity to the firstsealing overlap valve1100. Thelip seal1000 may be attached to the mountingring110 of theoverlap valve1100. One advantage of this arrangement is the very low profile of the device. Both thefirst sealing valve1100 and thesecond sealing valve1000 are located, in use, within the abdomen distally of the wound opening, and adjacent to the distal end of the wound retractor device.

Referring toFIG. 46, in this case the retractor has an outer mounting ring180 of the type described above with reference to FIGS.39 to41. The second sealinglip seal valve1000 is attached to the mountingring110 of the firstsealing overlap valve1100 which in turn is located in anouter recess183 of the mounting ring180.

Thefirst sealing valve1100 is located adjacent and in close proximity to thesecond sealing valve1000. Both thefirst sealing valve1100 and thesecond sealing valve1000 are located, in use, externally of the abdomen proximally of the wound opening, and adjacent to the proximal end of the wound retractor device.

As an alternative, one or both of the sealing valves may be located within the wound opening.

InFIGS. 47 and 48, the second sealingvalve lip seal1000 is located within the firstsealing overlap valve1100. The body of thelip seal1000 is located between the

flaps

102,103 of theoverlap valve1100. This device has a particularly low profile.

Referring toFIG. 49 to54, there is illustrated anothersurgical sealing device251 comprising a first sealing overlap valve of the type described above.

The mountingring145 provides a platform for mounting asecond sealing valve250, such as an iris-type valve to theretractor140. In this case, the,valve250 may be regarded as a primary valve and the overlap valve as a secondary valve.

In use, the space beneath theabdominal wall141 is insufflated. Theprimary valve250 is normally closed and is opened for insertion of an object, such as a laparoscopic instrument or a surgeon's hand/forearm105. On opening of thevalve250 the secondary overlap valve holds back the pressure of the gas inside the abdomen (FIG. 52). When thevalve250 has engaged around the surgeon's forearm105 (FIG. 53), theprimary valve250 provides a seal preventing gas leakage between the surgeon'sforearm105 and thevalve250. The surgeon can then readily open the secondary seal of the overlap valve whilst maintaining pneumoperitoneum. Thus, sealed access is provided without substantial gas leakage from the abdominal cavity. It will be noted, especially fromFIG. 54 that the secondary overlap valve, in this case, does not tightly seal around the surgeon'sarm105 but rather there are leak paths149 between thearm105 and the sealing-

members

102,103. Gas leakage is held back by the sealedprimary valve250.

The valve system of the invention is easy to use by a surgeon and yet avoids substantial gas leakage. Because thevalve250 is sealed to a surgeon's arm, the secondary overlap valve can be readily and safely opened to allow access into the abdominal cavity. The secondary overlap valve provides an effective seal against gas leakage while a surgeon seals his arm to theprimary valve250. Upon opening of the secondary overlap valve, theprimary valve250 then provides the primary seal against gas leakage.

In this case, the sealing

members

102,103 are of a gel material. However it will be appreciated that the sealing

members

102,103 may alternatively be provided in the form of any suitable elastic material, for example neoprene.

Referring toFIGS. 55 and 56, there is illustrated another surgical assembly similar to that of FIGS.49 to54. In this case the second sealing valve is aninflatable valve165, which may be of the type described in our U.S. Pat. No. 6,578,577, the whole contents of which are incorporated herein by reference. Thevalve165 is in this case mounted to the retractor base by a mountingsleeve166 having a reinforcingring167 which may be hooked over the mountingring145. Other mounting arrangements are possible. This type of inflatable valve/seal provides for easy and rapid hand insertion and withdrawal.

Referring to FIGS.57 to59, there is illustrated another surgical assembly which is similar to that ofFIGS. 55 and 56. In this case the second sealing valve170 is inflatable. The valve170 has an attachment ring171 for attachment to a mountingring172 of the retractor. In this case theattachment ring172 has arecess173 to accommodate the attachment, ring171 of the valve170. InFIG. 57, anaccess channel177 through the valve170 is illustrated in a closed sealing configuration. InFIGS. 58 and 59, theaccess channel177 has been opened to sealingly engage a surgeon'sarm105 extending therethrough.

In some of the described embodiments above the first sealing overlap valve is located adjacent to a distal end of the incision. It is also possible to provide the first sealing overlap valve externally of the abdomen proximally of the wound opening. For example, as illustrated inFIG. 60, a retractor may have a mountingring280, and the mountingring110 of the firstsealing overlap valve281 may be mounted to the mountingring280, for example by engagement in arecess283 in the mountingring280, as illustrated. In this case, a valve sleeve is not necessary.

Various other mounting arrangements are possible. For example, as illustrated inFIGS. 61 and 62, the firstsealing overlap valve190 may be mounted by hooking over thedistal ring142 of the retractor. In this case, thevalve190 has acuff191 with a reinforcingring192 to facilitate ease of mounting to the retractor.

Referring toFIGS. 63 and 64, there is illustrated a furthersurgical sealing device300 according to the invention. Thedevice300 comprises afirst sealing member301 and asecond sealing member302. Each sealing

member

301,302 has a

passageway

303,304 extending therethrough. The

passageways

303,304 are arranged out of alignment with respect to one another. In this manner, thefirst sealing member301 overlaps the entire periphery of the distal end opening of thepassageway304, and thesecond sealing member302 overlaps the entire periphery of the proximal end opening of thepassageway303. Thus in the closed configuration illustrated inFIG. 64, thedevice300 maintains an effective seal across a wound opening.

The sealing

members

303,304 are of an elastomeric gel material. The sealing

members

303,304 may therefore be manipulated to align the two

passageways

303,304, and thereby facilitate passage of an object, such as a laparoscopic instrument or a surgeon's hand/forearm, through thedevice300 to access the abdomen.

Each

passageway

303,304 is in the form of a lip-seal, and is capable of effecting a gas-tight seal between the wall of the

passageway

303,304 and the object inserted therethrough. Thus insufflation gas is prevented from escaping from the abdomen while the object is inserted through the

passageways

303,304.

InFIG. 65, there is illustrated anothersurgical sealing device310 according to the invention, which is similar to thedevice1 of FIGS. I to8, and similar elements inFIG. 65 are assigned the same reference numerals.

In this case, thefirst sealing member5 is attached to thesecond sealing member6 at theattachment region7 by means of a hinge arrangement. Thefirst sealing member5 is thus movable in a hinging motion relative to thesecond sealing member6 between the open and closed configurations.

For enhanced sealing in the closed configuration, a biasing member may be provided to bias thedetachment region8 of thefirst sealing member5 towards engagement with thesecond sealing member6, and thus bias thedevice320 towards the closed configuration. A suitable biasing member is amagnetic element321 on thefirst sealing member5 and a co-operatingmagnetic element322 on thesecond sealing member6, as illustrated inFIG. 66.

Alternative biasing members include velcro strips, or a latch.

FIGS.67 to70 illustrate anothersurgical sealing device330 according to the invention, which is similar to thedevice1 of FIGS.1 to8, and similar elements in FIGS.67 to70 are assigned the same reference numerals.

In this case, thefirst sealing member5 is attached to thesecond sealing member6 by means of aresilient cantilever arm331. Thearm331 acts as a leaf-spring to bias thefirst sealing member5 towards engagement with the distal end opening of thepassageway2, and thus bias thedevice330 towards the closed configuration.

Thefirst sealing member5 has a partially spherical,curved portion332 which partially extends into thepassageway2 in the closed configuration.

Referring toFIGS. 71 and 72, there is illustrated anothersurgical sealing device340 according to the invention, which is similar to thedevice1 of FIGS.1 to8, and similar elements inFIGS. 71 and 72 are assigned the same reference numerals.

In this case thefirst sealing member5 is provided in the form of a substantially spherical ball. In the closed configuration, thesphere5 engages the distal end opening of thepassageway2 to effect a gas-tight seal. Part of thesphere5 extends into thepassageway2 in the closed configuration.

Thesphere5 is attached to the distal side of thesecond sealing member6 by means of tworesilient cords341. Thecords341 act as spring members to bias thesphere5 towards engagement with the distal end opening of thepassageway2, and thus bias thedevice340 towards the closed configuration.

It will be appreciated that thefirst sealing member5 may be attached to thesecond sealing member6 in a variety of possible arrangements. For example, a singleresilient cord341 may extend from thesphere5 through thepassageway2 and be attached to the proximal side of thesecond sealing member6, as illustrated inFIGS. 73 and 74.

In FIGS.75 to78 there is illustrated anothersurgical sealing device405 according to the invention, which is similar to thedevice1 of FIGS.1 to8, and similar elements in FIGS.75 to78 are assigned the same reference numerals.

Thedevice405 may be used in a laparoscopic procedure to effect a seal around a laparoscopic instrument inserted through thedevice405 into an abdomen to maintain insufflation gas pressure within the abdomen. Alternatively, thedevice405 may be used in a hand-assisted laparoscopic procedure to effect a seal around a surgeon's hand or forearm inserted through thedevice405 into the abdomen to maintain insufflation gas pressure within the abdomen.

In this case thedevice405 comprises aplanar support element406 fixedly attached to the proximalexterior surface408 of thefirst sealing member5. Thesupport element406 may be provided by any suitable material, such as fabric or plastic or rubber or metal. Thesupport element406 may be attached to thefirst sealing member5 by any suitable means, such as by heat-sealing or by adhesive-backing or by gluing.

As discussed previously with reference to FIGS.1 to8, thefirst sealing member5 is fixedly attached to thesecond sealing member6 at an attachedregion409, with adetached region407 remaining detached from thesecond sealing member6.

Thesupport element406 acts as a stiffening element to increase the stiffness of thedetached region407 of thefirst sealing member5. By stiffening thedetached region407 of thefirst sealing member5, thesupport element406 minimises the deformation of thedetached region407 of thefirst sealing member5 when the instrument or the surgeon's hand/forearm3 is pushed through the passageway2 (FIG. 78). In particular any deformation of thedetached region407 in the direction perpendicular to the plane of thefirst sealing member5 is minimised.

Thus because there is a minimum of deformation of thefirst sealing member5, it is easier for the surgeon to retract thefirst sealing member5 laterally to reveal the distal end opening of thepassageway2 by pushing the instrument or the hand/forearm3 through the passageway2 (FIG. 78). It is therefore also easier for the surgeon to pass the instrument or the hand/forearm3 through thedevice405 and gain access to theabdomen4 because of the support provided by thesupport element406 to thefirst sealing member5.

As illustrated inFIG. 78, when the surgeon pushes the hand/forearm3 through thepassageway2, the fingers of thehand3 engage the proximal side of thefirst sealing member5. Further pushing of the hand/forearm3 distally will cause thefirst sealing member5 to be retracted laterally to reveal the distal end opening of thepassageway2, and without causing any substantial deformation of thedetached region407 of thefirst sealing member5.

The attachedregion409 of thefirst sealing member5 is not stiffened by thesupport element406, and the attachedregion409 retains the required elasticity to facilitate retraction of thefirst sealing member5 to reveal the distal end opening of thepassageway2.

FIGS. 79 and 80 illustrate anothersurgical sealing device410 according to the invention, which is similar to thedevice405 of FIGS.75 to78, and similar elements inFIGS. 79 and 80 are assigned the same reference numerals.

In this case, thesupport element406 is embedded within thefirst sealing member5, as illustrated inFIG. 80.

Because thesupport element406 supports thedetached region407, this ensures that it is not difficult for the surgeon to retract thefirst sealing member5 to reveal the distal end opening of thepassageway2 by inserting the instrument or the hand/forearm3 through thepassageway2. In particular, thefirst sealing member5 is supported and so does not deform distally downwardly perpendicular to the plane of thefirst sealing member5 when the surgeon pushes the instrument or the hand/forearm3 through thepassageway2. In such a manner it is relatively easy for the surgeon to access theabdomen4 because thefirst sealing member5 is prevented from deforming distally downwardly and instead is retracted to reveal the distal end opening of thepassageway2.

It will be appreciated that the support element feature as described above with reference to FIGS.75 to80 may be employed with any of the surgical sealing devices described previously with reference to FIGS.1 to74.

The invention is not limited to the embodiments hereinbefore described, with reference to the accompanying drawings, which may be varied in construction and detail.